UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011236
Receipt number R000013167
Scientific Title Evaluation of efficacy of mesalazine suppository in ulcerative colitis with rectal inflammation -Efficacy of on-demand therapy for induction and maintenance of remission -
Date of disclosure of the study information 2013/07/20
Last modified on 2016/01/20 15:05:59

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Basic information

Public title

Evaluation of efficacy of mesalazine suppository in ulcerative colitis with rectal inflammation -Efficacy of on-demand therapy for induction and maintenance of remission -

Acronym

Evaluation of efficacy of mesalazine suppository in ulcerative colitis with rectal inflammation

Scientific Title

Evaluation of efficacy of mesalazine suppository in ulcerative colitis with rectal inflammation -Efficacy of on-demand therapy for induction and maintenance of remission -

Scientific Title:Acronym

Evaluation of efficacy of mesalazine suppository in ulcerative colitis with rectal inflammation

Region

Japan


Condition

Condition

Ulcerative colitis

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To prospectively evaluate efficacy of mesalazine suppository in Japanese ulcerative colitis patients with active rectal inflammation

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Time to disappearance of rectal bleeding
Rate of disappearance of rectal bleeding
Rate of adverse events

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Upon appearance of rectal bleeding, once daily administration of a 500 mg mesalazine suppository until disappearance of rectal bleeding.

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

15 years-old <=

Age-upper limit

65 years-old >

Gender

Male and Female

Key inclusion criteria

1. Ulcerative colitis patients with rectal inflammation who has rectal bleeding or in remission.

2. Patients with the first attack or those in remission on salazopyrine or mesalazine less than 4 grams daily.

Key exclusion criteria

1. Past history of adverse effect to mesalazine.

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Katsuyoshi Matsuoka

Organization

Keio University School of Medicine

Division name

Gastroenterology and Hepatology

Zip code


Address

35 Shinanomachi, Shinjuku Tokyo

TEL

03-3353-122

Email

matsuoka@z2.keio.jp


Public contact

Name of contact person

1st name
Middle name
Last name Katsuyoshi Matsuoka

Organization

Keio University School of Medicine

Division name

Gastroenterlogy and Hepatology

Zip code


Address

35 Shinanomachi, Shinjuku Tokyo

TEL

03-3353-1211

Homepage URL


Email

matsuoka@z2.keio.jp


Sponsor or person

Institute

Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2013 Year 07 Month 20 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2011 Year 05 Month 02 Day

Date of IRB


Anticipated trial start date

2011 Year 05 Month 02 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 07 Month 20 Day

Last modified on

2016 Year 01 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013167


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name